Service Description

Preliminary Tox studies should be performed in the best manner possible and gleam the most amount of data. In comparison this is a "cheap" study that will be a value driver for the actual GLP tox and safety evaluation in a dose response manner.

What Went Well

Covance has a large amount of experience in dosing antibodies and should therefore have assays for the evaluation of potential antibodies. Also with antibodies ng/kg may be a better starting point with dose escalation in the same population of na

What Could Be Improved

Potentially better communication and description of prior experience in this area and with antibodies. A more proactive approach with several options would provide a better overview and risk assessment of this study.

Lessons Learned from the Experience

As always the most important thing is interactions with key scientific partners at the CRO, which allows to build a history and rust between the provider and the client. This then allows for a better protocol and evaluation of a drug substance/program.